Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113110579 | 11311057 | 9 | F | 20150528 | 20160816 | 20150727 | 20160822 | PER | PHEH2015US010405 | NOVARTIS | 57.42 | YR | F | Y | 63.39000 | KG | 20160822 | CN | COUNTRY NOT SPECIFIED | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113110579 | 11311057 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 113110579 | 11311057 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | F0017/F0023 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 113110579 | 11311057 | 3 | C | CARBAMAZEPIN ER | 2 | Oral | 400 MG, BID | U | 0 | 400 | MG | BID | |||||||
| 113110579 | 11311057 | 4 | C | CARBAMAZEPIN ER | 2 | U | 0 | ||||||||||||
| 113110579 | 11311057 | 5 | C | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | Oral | 100 MG, QHS (NIGHT) | Y | 0 | 100 | MG | |||||||
| 113110579 | 11311057 | 6 | C | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | Oral | 50 MG, QHS | Y | 0 | 50 | MG | |||||||
| 113110579 | 11311057 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 113110579 | 11311057 | 8 | C | LYRICA | PREGABALIN | 1 | Oral | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 113110579 | 11311057 | 9 | C | LYRICA | PREGABALIN | 1 | U | 0 | |||||||||||
| 113110579 | 11311057 | 10 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 1000 IU, QD | U | 0 | 1000 | IU | QD | ||||||
| 113110579 | 11311057 | 11 | C | ESTRACE | ESTRADIOL | 1 | Oral | 0.1 MG, QHS | 0 | .1 | MG | ||||||||
| 113110579 | 11311057 | 12 | C | MULTI VITAMIN | VITAMINS | 1 | Oral | 1 DF, QD | 0 | 1 | DF | QD | |||||||
| 113110579 | 11311057 | 13 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Oral | 1500 UG, QD | 0 | 1500 | UG | QD | |||||||
| 113110579 | 11311057 | 14 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | Oral | 1200 MG, QD | 0 | 1200 | MG | QD | |||||||
| 113110579 | 11311057 | 15 | C | CALCIUM | CALCIUM | 1 | Oral | 500 MG, QD | 0 | 500 | MG | QD | |||||||
| 113110579 | 11311057 | 16 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 113110579 | 11311057 | 17 | C | MAGNESIUM | MAGNESIUM | 1 | Oral | 500 MG, QD | U | 0 | 500 | MG | QD | ||||||
| 113110579 | 11311057 | 18 | C | TEGRETOL XR | CARBAMAZEPINE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113110579 | 11311057 | 1 | Multiple sclerosis |
| 113110579 | 11311057 | 3 | Sleep disorder |
| 113110579 | 11311057 | 4 | Pain |
| 113110579 | 11311057 | 5 | Bipolar disorder |
| 113110579 | 11311057 | 7 | Gastrooesophageal reflux disease |
| 113110579 | 11311057 | 8 | Multiple sclerosis |
| 113110579 | 11311057 | 9 | Pain |
| 113110579 | 11311057 | 10 | Multiple sclerosis |
| 113110579 | 11311057 | 11 | Vulvovaginal injury |
| 113110579 | 11311057 | 12 | Multiple sclerosis |
| 113110579 | 11311057 | 13 | Multiple sclerosis |
| 113110579 | 11311057 | 14 | Dry eye |
| 113110579 | 11311057 | 15 | Bone disorder |
| 113110579 | 11311057 | 16 | Hypothyroidism |
| 113110579 | 11311057 | 17 | Dyspepsia |
| 113110579 | 11311057 | 18 | Neuralgia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113110579 | 11311057 | Balance disorder | |
| 113110579 | 11311057 | Blood cholesterol increased | |
| 113110579 | 11311057 | Cognitive disorder | |
| 113110579 | 11311057 | Fatigue | |
| 113110579 | 11311057 | Food craving | |
| 113110579 | 11311057 | Headache | |
| 113110579 | 11311057 | Musculoskeletal pain | |
| 113110579 | 11311057 | Nasopharyngitis | |
| 113110579 | 11311057 | Neck pain | |
| 113110579 | 11311057 | Pain in extremity | |
| 113110579 | 11311057 | Vomiting | |
| 113110579 | 11311057 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 113110579 | 11311057 | 1 | 20150209 | 0 | ||
| 113110579 | 11311057 | 2 | 20150228 | 0 | ||
| 113110579 | 11311057 | 3 | 201404 | 0 | ||
| 113110579 | 11311057 | 5 | 201409 | 20150613 | 0 | |
| 113110579 | 11311057 | 6 | 20150613 | 0 | ||
| 113110579 | 11311057 | 7 | 200503 | 0 | ||
| 113110579 | 11311057 | 8 | 200503 | 0 | ||
| 113110579 | 11311057 | 10 | 201404 | 0 | ||
| 113110579 | 11311057 | 11 | 201204 | 0 | ||
| 113110579 | 11311057 | 12 | 2000 | 0 | ||
| 113110579 | 11311057 | 13 | 2010 | 0 | ||
| 113110579 | 11311057 | 14 | 201003 | 0 | ||
| 113110579 | 11311057 | 15 | 201003 | 0 | ||
| 113110579 | 11311057 | 16 | 200503 | 0 | ||
| 113110579 | 11311057 | 17 | 201404 | 0 | ||
| 113110579 | 11311057 | 18 | 20160120 | 0 |